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Sperm Motility and IUI Live Birth Rate

Intrauterine Insemination Outcomes Based on WHO 2021 Manual Assessment of Total Rapidly Progressing Motile Sperm Count

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06117995
Acronym
IUI
Enrollment
536
Registered
2023-11-07
Start date
2023-11-01
Completion date
2025-12-30
Last updated
2023-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

sperm motility, rapid progressive motile sperm, WHO 2021, intrauterine insemination, live birth rate

Brief summary

This prospective cohort study aims to establish a cut-off threshold for pre-washed total rapidly motile sperm count (TRMSC) based on WHO 2021 criteria to predict the live birth rate following intrauterine insemination (IUI). The study seeks to answer two key questions: 1. Is there a correlation between TRMSC, as per the WHO 2021 criteria, and the live birth rate after IUI? 2. What is the appropriate cut-off threshold of TRMSC to predict a positive live birth outcome after IUI? Couples undergoing ovulation induction and IUI for indicated reasons will participate in the study. On the day of insemination, the pre-washed semen from the husband will be assessed according to the WHO 2021 criteria. The outcomes of the IUI procedure will be documented.

Detailed description

Eligible patients will be enrolled in the study on the day of intrauterine insemination (IUI). Both spouses will receive detailed information about the study and provide informed consent. Sperm motility will be evaluated according to the WHO 2021 guidelines before filtration and washing. Ovarian stimulation will be conducted using human menopausal gonadotropins (hMG) with regular ultrasound monitoring of follicular development. Once the lead follicle reaches a size of 18mm, ovulation will be induced using hCG. If six or more follicles reach a size of 14mm, the patient will be advised to cancel the cycle or consider in-vitro fertilization (IVF). IUI will be performed 36-38 hours after hCG injection. For patients who prefer non-injection-based ovarian stimulation, an oral agent using letrozole will be offered. Letrozole with a dosage of 5 to 7.5 mg will be administered orally from days 2-5 of the menstrual cycle, and ovarian follicle development will be assessed through ultrasound on day 10. Sperm samples will be collected through masturbation at the hospital after a period of 2-5 days of ejaculation abstinence. Motility analysis will be performed based on the WHO 2021 guidelines, which classify sperm as rapid progressive (A), slow progressive (B), non-progressive (C), or immotile (D), using the formula: percentage of rapid progressive sperm x density x volume. Semen parameters, including volume, density, and normal morphology ratio, will also be evaluated according to the WHO 2021 guidelines. The collected sample will undergo processing using the density gradient method, following the WHO 2021 guidelines. The processed semen will be used for IUI, and its concentration and motility will be examined. During the insemination procedure, a Gynétic soft catheter will be used. After the procedure, the patient will rest for 15 - 20 minutes, followed by luteal-phase support using vaginal micronized progesterone for 14 days. The presence of hCG in the blood will be tested after 14 days to determine a biochemical pregnancy. Confirmation of clinical pregnancy will be based on ultrasound observation of a gestational sac at 7 weeks of gestational age. Prenatal care until delivery will be provided either at specified hospitals or through regular contact. During delivery, data on labour, delivery, and any complications experienced by the participant or newborn will be collected. Participants who cannot attend prenatal care at the designated hospitals will be contacted regularly for data collection. Descriptive analysis will be used to describe the background characteristics of the study population, presenting continuous variables as means and standard deviations (SD) and comparing them using appropriate statistical tests. Categorical variables will be presented as percentages and compared using relevant statistical tests such as Pearson's chi-square or Fisher's exact test.

Interventions

OTHERAssessment the pre-washed sperm motility before IUI

The pre-washed sperm motility will be assessed by using WHO 2021 guidelines, stratified into four groups.

Sponsors

Mỹ Đức Phú Nhuận Hospital
CollaboratorUNKNOWN
Phương Chi Hospital
CollaboratorUNKNOWN
Mỹ Đức Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patient undergoing IUI * Undergone \<4 previous IUI cycles * Total progressive motility sperm count before sperm preparation: \> 5million * Agree to participate in the study

Exclusion criteria

* Using frozen semen

Design outcomes

Primary

MeasureTime frameDescription
Live birth rateAt 24 weeks of gestationLive birth is defined as the complete expulsion or extraction from a woman of a product of fertilization, after 24 completed weeks of gestational age; which, after such separation, breathes or shows any other evidence of life, such as heart beat, umbilical cord pulsation or definite movement of voluntary muscles, irrespective of whether the umbilical cord has been cut or the placenta is attached. A birth weight of 500 grams or more can be used if gestational age is unknown. In the analysis for the primary endpoint, twin delivery will be considered.

Secondary

MeasureTime frameDescription
Biochemical pregnancy rateAt 14 days after inseminationBiochemical pregnancy defined as a serum beta-hCG level greater than 25 mIU/ml at day 14 after insemination
Clinical pregnancy rateAt 7 weeks of gestationClinical pregnancy defined as the presence of at least one gestational sac on ultrasound at week 7 of gestation with the detection of heart beat activity, after insemination
Miscarriage rateBefore 22 weeks of gestational ageMiscarriage defined as spontaneous loss of a clinical pregnancy before week 22 of gestational age, in which the embryo(s) or fetus(es) is/are nonviable and is/are not spontaneously absorbed or expelled from the uterus.
Multiple pregnancy rateAt 7 weeks of gestationMultiple pregnancy defined as two or more gestational sacs or two or more positive heart beats by transvaginal sonography
Total motile sperm count after sperm preparationAt 5 minutes after sperm preparation for IUITotal motile sperm count after sperm preparation, measured by million sperm
Gestational age at deliveryAt birthGestational age at delivery.
Birth weighAt birthWeight of newborn
Stillbirth rateAfter 28 completed weeks of gestational ageStillbirth defined as the death of a fetus prior to the complete expulsion or extraction from its mother
Congenital abnormalities rateAt birthAny congenital abnormalities detected in the newborn
Preterm delivery rateAt birthPreterm delivery is defined as any delivery at \<24, \<28, \<32, \<37 completed weeks' gestation

Contacts

Primary ContactTuong M Ho
tuong.hm@myduchospital.vn+84 02873085885
Backup ContactTuyen D Duong
tuyen.dnd@myduchospital.vn+84979369699

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026